MAUDE Adverse Event Report: TORNIER INC PERFORM HUMERAL STEM SZ 3; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER + ADDITIVE, CEMENTED

Catalog Number	DWX3SS
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Loss of Range of Motion (2032); Discomfort (2330); Implant Pain (4561)
Date of Event	05/14/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.Should additional information become available, it will be provided in a supplemental report.
Event or Problem Description
As reported: subject: (b)(6) phs stemless study.Unexpected pain.She reports that she has started to notice some pain and discomfort with daily activities like reaching behind her for hygiene.She also reports pain when raising her arm overhead.She is unable to use her right arm to lift anything.Ct was ordered and results were reviewed with the subject.Ct results: bony remodeling along the anterior proximal humerus.No evidence of gross loosening.Minimal degenerative changes of the acromioclavicular joint.Prominent anterosuperior glenoid osteophyte formation adjacent to the peripheral margin of the glenosphere.Surgical clips noted within the right axillary region without lymphadenopathy.Visualized right lung field demonstrates scattered groundglass opacities in the upper lobe anteriorly.Atherosclerotic vascular calcifications.No joint effusion or periarticular fluid collection.No evidence for acromial stress fracture.".
Additional Manufacturer Narrative
The reported event could not be confirmed since the device was not returned for evaluation and provided x ray images are insufficient for the hcp evaluation.The device inspection was not possible as the product was not returned for investigation.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.However, on the available x rays medical opinion was sought from an experienced independent medical expert as below.The x rays do not show any factor that could explain pain as such.The implant is well-fixed and well-positioned on both the humeral and glenoid side.More detailed information or clinical information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.If device is returned or any further information is provided the investigation report will be reassessed.
Event or Problem Description
As reported: subject: 08-003 phs stemless study unexpected pain.She reports that she has started to notice some pain and discomfort with daily activities like reaching behind her for hygiene.She also reports pain when raising her arm overhead.She is unable to use her right arm to lift anything.Ct was ordered and results were reviewed with the subject.Ct results: bony remodeling along the anterior proximal humerus.No evidence of gross loosening.Minimal degenerative changes of the acromioclavicular joint.Prominent anterosuperior glenoid osteophyte formation adjacent to the peripheral margin of the glenosphere.Surgical clips noted within the right axillary region without lymphadenopathy.Visualized right lung field demonstrates scattered groundglass opacities in the upper lobe anteriorly.Atherosclerotic vascular calcifications.No joint effusion or periarticular fluid collection.No evidence for acromial stress fracture.".

• Brand Name: PERFORM HUMERAL STEM SZ 3
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER + ADDITIVE, CEMENTED
• Manufacturer (Section D): TORNIER INC; 10801 nesbitt avenue s; bloomington MN 55437
• Manufacturer (Section G): TORNIER INC; 10801 nesbitt avenue s; bloomington MN 55437
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 20393633
• Report Number: 0001649390-2024-00569
• Device Sequence Number: 15440051
• Product Code: PAO
• UDI-Device Identifier: 00846832085477
• UDI-Public: 00846832085477
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K201315
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: DWX3SS
• Device Lot Number: 5626AY
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/10/2024
• Supplement Date Received by Manufacturer: 12/10/2024
• Initial Report FDA Received Date: 10/08/2024
• Supplement Report FDA Received Date: 01/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/20/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Weight: 69 KG